BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3150 INFO CNTR LOCAL DATABASE REL N.0

    MDR report key: 10922313 · Received November 30, 2020

    Report

    Report Number
    1218950-2020-07326
    Event Type
    Death
    Date Received
    November 30, 2020
    Date of Event
    December 9, 2020
    Report Date
    November 26, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER. THE RCE WAS INFORMED THAT THE ISSUE OCCURRED ON (B)(6) 2020 AT 8:16AM. THE RCE WAS PROVIDED THE ALARM LOG FROM THE PIIC CENTRAL STATION, AND REVIEWED THE LOGS. THE RCE NOTED THAT JUST BEFORE THE EVENT, THERE WAS A THREE MINUTE SUSPENSION OF ALARMS. THE RCE FOUND NO OTHER ENTRIES DURING THE EVENT AT 8:15AM. THIS INDICATES THAT NO RED ALARM HAD GONE OFF. THE CLASSIC PIIC DOES NOT TRACE THE YELLOW AND BLUE ALARMS. THIS ANALYSIS CORROBORATES THE EXPLANATIONS PROVIDED BY THE CUSTOMER FOR THE PRESENCE OF A YELLOW ALARM ON INVASIVE PRESSURE. BECAUSE THE EXTREME ALARMS ON THE INVASIVE PRESSURE WERE NOT ACTIVATED, THERE WERE NO RED ALARMS TRIGGERED ON HE PIIC. THE RCE NOTED THAT INTENSIVE CARE UNIT (ICU) PATIENTS WERE BEING TRANSFERRED TO ANOTHER WARD (USC WARD), WHICH HAD BEEN CONFIGURED APPROPRIATELY. HOWEVER, DUE TO PATIENTS ARRIVING IN THE CRITICAL CARE UNIT (CCU), THIS CONFIGURATION WAS NO LONGER SUITABLE. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A CONFIGURATION ISSUE. A PHILIPS APPLICATION ENGINEER (AE) WILL CONSULT WITH THE CUSTOMER TO REVIEW THE CONFIGURATION WITH THE SERVICE AND DOCTORS. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. NO FURTHER DETAILS REGARDING THE PATIENT STATUS HAVE BEEN RECEIVED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPDATED: OUTCOMES ATTRIBUTED TO ADVERSE EVENT, DATE OF EVENT, TYPE OF REPORTABLE EVENT, ADVERSE EVENT PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO RED ALARM ON THE PHILIPS INTELLIVUE INFORMATION CENTER (PIIC) CENTRAL STATION. IT WAS A PROBLEM WITH A LOW INVASIVE PRESSURE ALARM; IT SOUNDED YELLOW INSTEAD OF RED. THE PATIENT COULD NOT BE TAKEN CARE OF QUICKLY ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388346 M3150 INFO CNTR LOCAL DATABASE REL N.0 CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS M3150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death